Impact of Mediating and Confounding Variables on the Volume-Outcome Association in the Treatment of Pancreatic Cancer.

BACKGROUND: High-volume centers (HVC), academic centers (AC), and longer travel distances (TD) have been associated with improved outcomes for patients undergoing surgery for pancreatic adenocarcinoma (PAC). Effects of mediating variables on these associations remain undefined. The purpose of this study is to examine the direct effects of hospital volume, facility type, and travel distance on overall survival (OS) in patients undergoing surgery for PAC and characterize the indirect effects of patient-, disease-, and treatment-related mediating variables. PATIENTS AND METHODS: Using the National Cancer Database, patients with non-metastatic PAC who underwent resection were stratified by annual hospital volume (< 11, 11-19, and ≥ 20 cases/year), facility type (AC versus non-AC), and TD (≥ 40 versus < 40 miles). Associations with survival were evaluated using multiple regression models. Effects of mediating variables were assessed using mediation analysis. RESULTS: In total, 19,636 patients were included. Treatment at HVC or AC was associated with lower risk of death [hazard ratio (HR) 0.90, confidence interval (CI) 0.88-0.92; HR 0.89, CI 0.86-0.91, respectively]. TD did not impact OS. Patient-, disease-, and treatment-related variables explained 25.5% and 41.8% of the survival benefit attained from treatment at HVC and AC, reducing the survival benefit directly attributable to each variable to 4.9% and 6.4%, respectively. CONCLUSIONS: Treatment of PAC at HVC and AC was associated with improved OS, but the magnitude of this benefit was less when mediating variables were considered. From a healthcare utilization and cost-resource perspective, further research is needed to identify patients who would benefit most from selective referral to HVC or AC.

Impact of Adherence to Operative Standards and Stage-Specific Guideline-Recommended Therapy in Nonmetastatic Pancreatic Adenocarcinoma.

BACKGROUND: Achieving optimal surgical outcomes in pancreatic adenocarcinoma requires a combination of both curative-intent resection to oncologic standards and stage-specific neoadjuvant or adjuvant therapy. This investigation sought to examine factors associated with receipt of standard-adherent surgery (SAS) and guideline-recommended therapy (GRT) and determine the impact of compliance on patient survival. PATIENTS AND METHODS: From the 2006-2016 National Cancer Database, 21,304 patients underwent resection for nonmetastatic pancreatic adenocarcinoma. SAS was defined as pancreatic resection with negative margins and ≥ 15 lymph nodes examined. Stage-specific GRT was defined by current National Comprehensive Cancer Network guidelines. Multivariable models were used to determine predictors of adherence to SAS and GRT and prognostic impact on overall survival. RESULTS: Overall, SAS was achieved in 39% and GRT in 65% of patients, but only 30% received both SAS and GRT. Increasing age, minority race, uninsured status, and greater comorbidities were associated with a decreased odds of receiving both SAS and GRT (all p < 0.05). SAS (HR 0.79; CI 0.76-0.81; p < 0.001) and GRT (HR 0.67; CI 0.65-0.69; p < 0.001) were each independently associated with a survival advantage. Receipt of both SAS and GRT was associated with significant improvement in median OS compared with receiving neither (2.2 years vs 1.1 years; p < 0.001) which was independently associated with a 78% increased risk of death (HR 1.78; CI 1.70-1.86; p < 0.001). CONCLUSIONS: Despite survival benefits associated with adherence to operative standards and receipt of guideline-recommended therapy, compliance remains poor. Future efforts must be directed toward improved education and implementation efforts around both operative standards and therapy guidelines.

Preoperative Risk Prediction for Pancreatectomy: A Comparative Analysis of Three Scoring Systems.

INTRODUCTION: Pancreatectomy is associated with high morbidity and mortality. Therefore, patient selection and risk prediction is paramount. In this study, three validated perioperative risk scoring systems were compared among patients undergoing pancreatectomy to identify the most clinically useful model. MATERIALS AND METHODS: The 2014-2017 American College of Surgeons National Surgical Quality Improvement Program database was queried for pancreatectomy patients. Three models were evaluated: National Surgical Quality Improvement Program Universal Risk Calculator (URC), Model for End-Stage Liver Disease (MELD), and Modified Frailty Index-5 Factor (mFI-5). Outcomes were 30-d mortality and complications. Predictive performance of the models was compared using area under the receiver operating characteristic curve (AUC) and Brier scores. RESULTS: Twenty two thousand one hundred twenty three pancreatectomy patients were identified. The 30-d mortality rate was 1.4% (n = 319). Complications occurred in 6020 cases (27.2%). AUC (95% CI) for 30-d mortality were 0.70 (0.67-0.73), 0.63 (0.60-0.67), and 0.60 (0.57-0.63) for URC, MELD, and mFI-5, respectively, with Brier score of 0.014 for all three models. AUC (95% confidence interval) for any complication was 0.59 (0.58-0.59) for URC, 0.53 (0.52-0.54) for MELD, and 0.53 (0.52-0.54) for mFI-5, with Brier scores 0.193 (URC), 0.200 (MELD), and 0.197 (mFI-5). For individual complications, URC was more predictive than MELD or mFI-5. CONCLUSIONS: Of the validated preoperative risk scoring systems, URC was most predictive of both complications and 30-d mortality. None of the models performed better than fair to good. The lack of predictive accuracy of currently existing models highlights the need for development of improved perioperative risk models.

The Dreaded 3-Minute Wait: Does It Really Prevent Operating Room Fires? The IGNITE Trial.

INTRODUCTION: Operating room fires can have devastating consequences and as such must be prevented. There exists a paucity of literature requiring further elucidation regarding manufacturer recommendations of a predefined waiting period prior to patient draping after using alcohol-based surgical antiseptics, in order to reduce the risk of operating room fires. METHODS: This was further investigated by exposing two common alcohol-based surgical antiseptics to electrosurgery and open flames at various power settings and time intervals in an ex vivo porcine model. The simulated surgical site was prepped following manufacturer recommendations and exposed to monopolar electrosurgery at low and high power, using both PURE CUT and COAGULATION modes, and open flame, at 15-s increments after application. RESULTS: While using PURE CUT mode at both low and high power, no ignition was observed on hairless surgical sites prepped with ChloraPrep® at any time point. However, use of COAGULATION mode at both low and high powers resulted in ignition consistently out to 1-min post-application. Additionally, if the prepped area subjectively appeared wet, especially with pooling of the antiseptic, both COAGULATION mode and open flame caused ignition. Dry time was found to be about 59 s for both prep solutions. It was also observed that the amount of pressure directly correlated with the amount of prep dispersed and increased dry times. CONCLUSION: In conclusion, our data suggest an average dry time of less than 1-min, with ignition only observed when the antiseptic was visibly wet. Ignition did not occur on hairless skin with electrocautery on CUT mode using ChloraPrep at any time point. Additionally, ignition on hair-bearing skin was not observed past 3 min, with current manufacturer recommendations stating 1 h wait time for hair-bearing skin. Arbitrarily waiting a specific predetermined dry time until patient draping, as recommended by the manufacturers, may be unnecessary and lead to hours' worth of time wasted each year. Ongoing research will further investigate the utility of drying the antiseptic after application and its affect on not only preventing ignition but also antimicrobial efficacy.

Comparing a Novel Hand-Held Device for Chest Tube Insertion to the Traditional Open Tube Thoracostomy for Simple Pneumothorax in a Porcine Model.

BACKGROUND: Tube thoracostomy is the most effective treatment for pneumothorax, and on the battlefield, is lifesaving. In combat, far-forward adoption of open thoracostomy has not been successful. Therefore, the ability to safely and reliably perform chest tube insertion in the far-forward combat theatre would be of significant value. The Reactor is a hand-held device for tube thoracostomy that has been validated for tension pneumothorax compared to needle decompression. Here we investigate whether the Reactor has potential for simple pneumothorax compared to open thoracostomy. Treatment of pneumothorax before tension physiology ensues is critical. METHODS: Simple pneumothoraces were created in 5 in-vivo swine models and confirmed with x-ray. Interventions were randomized to open technique (OT, n = 25) and Reactor (RT, n = 25). Post-procedure radiography was used to confirm tube placement and pneumothorax resolution. Video Assisted Thoracoscopic Surgery (VATS) was used to evaluate for iatrogenic injuries. 50 chest tubes were placed, with 25 per group. RESULTS: There were no statistical differences between the groups for insertion time, pneumothorax resolution, or estimated blood loss (p = .91 and .83). Injury rates between groups varied, with 28% (n = 7) in the Reactor group and 8% (n = 2) the control group (p = .06). The most common injury was violation of visceral pleura (10%, n = 5, both groups) and violation of the mediastinum (8%, n = 4, both groups). CONCLUSION: The Reactor device was equal compared to open thoracostomy for insertion time, pneumothorax resolution, and injury rates. The device required smaller incisions compared to tube thoracostomy and may be useful adjunct in simple pneumothorax management.

Meeting the New Commission on Cancer Operative Standards: Where Do We Stand Now?

INTRODUCTION: The 2020 Commission on Cancer accreditation standards 5.7 and 5.8 address total mesorectal excision for rectal cancer and lymph node sampling for lung cancer. The purpose of this review was to assess our institution's compliance with these operative standards, which will be required in 2022 and 2023, and provide recommendations to other military training facilities seeking to comply with these standards. MATERIALS AND METHODS: A 2018-2020 single institution chart review was performed of operative and pathology reports. Identified deficits were addressed in meetings with colorectal and thoracic surgery leadership, and cases were followed to reassess compliance. RESULTS: A total of 12 rectal and 48 lung cancer cases met the inclusion criteria and were examined. Pre-intervention compliance for standards 5.7 and 5.8 was 58% and 35%, respectively, because of inadequate synoptic reporting and lymph node sampling. After intervention, compliance was 100%. CONCLUSIONS: Our institution requires changes to comply with new standards, including in areas of documentation and systematic pulmonary lymph node sampling. We provide lessons learned from our own institutional experience, including practical tips and recommendations to achieve compliance. All military training facilities performing lung and rectal oncologic resections should conduct an internal review of applicable cases in preparation for upcoming American College of Surgeons Commission on Cancer site visits.

Assessing Surgical Task Load and Performance: A Comparison of Simulation and Maritime Operation.

INTRODUCTION: This study examined the effects of simulated and actual vessel motion at high seas on task load and surgical performance. METHODS: This project was performed in phases. Phase I was a feasibility study. Phase II utilized a motion base simulator to replicate vessel motion. Phase III was conducted aboard the U.S. Naval Ship Brunswick. After performing surgical tasks on a surgical simulation mannequin, participants completed the Surgical Task Load Index (TLX) designed to collect workload data. Simulated surgeries were evaluated by subject matter experts. RESULTS: TLX scores were higher in Phase III than Phase II, particularly at higher sea states. Surgical performance was not significantly different between Phase II (84%) and Phase III (89%). Simulated motions were comparable in both phases. CONCLUSIONS: Simulated motion was not associated with a significant difference in surgical performance or deck motion, suggesting that this simulator replicates the conditions experienced during surgery at sea on the U.S. Naval Ship Brunswick. However, Surgical TLX scores were dramatically different between the two phases, suggesting increased workload at sea, which may be the result of time at sea, the stress of travel, or other factors. Surgical performance was not affected by sea state in either phase.